Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo

NCT07683026 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TN39A
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if golimumab is effective at preventing progression to Stage 2 diabetes in participants with presymptomatic Type 1 Diabetes. The expected duration of this study is approximately 6 years. Participants will:

• Take golimumab or placebo injections monthly for the duration of the study or until they are diagnosed with either stage 2 or stage 3 Type 1 Diabetes
• Visit a study clinic every 6 months for Oral Glucose Tolerance Tests (OGTTs) and other tests until the end of the study

Conditions

Type 1 Diabetes (T1D)

Keywords

TrialNet; T1D; Golimumab

Outcome Measures

Primary Outcomes (1)

• Progression to Dysglycemia

  The primary outcome is the elapsed time from random treatment assignment to the development of confirmed dysglycemia or overt hyperglycemia/symptomatic based upon ADA criteria.

  From randomization to confirmed dysglycemia or clinical diagnosis of T1D, approximately 6 years from the first participant enrolled.

Secondary Outcomes (1)

• Progression to overt hyperglycemia/symptomatic Type 1 Diabetes

  From Randomization to clinical diagnosis approximately 6 years from the first participant enrolled.

Study Arms (2)

Golimumab

EXPERIMENTAL

Participants assigned to this arm will receive golimumab injections

Drug: Golimumab

Placebo

PLACEBO COMPARATOR

Participants assigned to this arm will receive saline (placebo) to match Golimumab injections

Drug: Placebo (matching golimumab)

Interventions

Golimumab DRUG

Golimumab will be given as a subcutaneous formulation based on the participant's weight at baseline. A loading dose regimen at 0 and 2 weeks will be followed by monthly maintenance doses for the duration of the participant's enrollment in the study. For those weighing 15kg to less than 40 kg the dosing will be: 100mg (week 0), followed by 50mg monthly thereafter. For those weighing 40kg or more the loading dose will be 200mg (week 0) followed by 100mg thereafter.

Also known as: Simponi

Golimumab

Placebo (matching golimumab) DRUG

0.9% Sodium Chloride Injection USP ("Normal" saline) is to be dispensed as the placebo for this study. A loading dose regimen at 0 and 2 weeks will be followed by monthly maintenance doses for the duration of the participant's enrollment in the study.

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 2 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is \<18 years of age.
• Weight ≥15 kg at the time of screening.
• Aged ≥2 to \<45 years.
• A confirmed history of either IA2A alone or at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. Confirmed autoantibody result means that the presence of the antibody has been verified on more than one occasion. For multiple autoantibody positivity, the same autoantibodies do not need to be present on the different tests. Confirmation must occur within the six months prior to screening. In the absence of other antibodies, ICA and GADA positivity alone will not suffice for eligibility in this study.
• Oral glucose tolerance test (OGTT) results demonstrating normal glucose tolerance within 7 weeks (52 days) prior to randomization. If a participant has known previous abnormal glucose tolerance, the two most recent OGTTs must demonstrate normal glucose tolerance to be eligible.
• CMV and/or EBV seronegative participants must be CMV and EBV PCR negative within 60 days of randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization.
• CMV seropositive participants must be CMV PCR negative and all EBV seropositive participants must have EBV PCR \< 2,000 IU/mL within 60 days of randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization.
• Be at least 4 weeks from last live immunization.
• Be willing to forgo live vaccines during treatment and for 3 months after study drug treatment period.
• Must meet TrialNet eligibility minimum immunization recommendations found in Appendix A of the manual of operations (MOO).
• Negative Coccidioides serology testing for those who have in the past resided in for at least 2 months, currently reside in, or within the past 2 months have visited an endemic area (as defined in Protocol MOO Appendix B).
• If a female participant with reproductive potential, willing to avoid pregnancy (abstinence or adequate contraceptive method) through up to 3 months after last study drug administration and undergo pregnancy testing at each study visit.

You may not qualify if:

• One or more screening laboratory values as stated:
• Leukocytes \<3,500/μL or \>14,000/μL
• Neutrophils \<1,500/mL
• Platelet count \<100,000 /μL
• Hemoglobin \<6.2 mmol/L (10.0 g/dL)
• AST or ALT ≥ 2 times the upper limits of normal (2x ULN)
• Abnormal Glucose Tolerance or Diabetes
• Fasting plasma glucose ≥100 mg/dL (6.1 mmol/L), or
• hour plasma glucose ≥140 mg/dL (7.8 mmol/L), or
• , 60, or 90 minute plasma glucose during OGTT ≥200 mg/dL (11.1 mmol/L)
• History of treatment with insulin except transient use during acute illness or hospitalization.
• Vaccination with a live vaccine within the last 4 weeks or killed/inactivated vaccine within the last 2 weeks prior to randomization.
• A history of confirmed infectious mononucleosis within the 3 months prior to randomization, as documented by EBV serology (EBV VCA-IgM and VCA-IgG; PCR would be confirmatory).
• Evidence of prior or current tuberculosis (TB) infection through any one or more of the following:
• A history of latent or active TB

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02115, United States

Location

Related Links

• TrialNet Public Website

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

golimumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jason Gaglia, MD

  TrialNet

  STUDY CHAIR

Central Study Contacts

Ariana Rojas

CONTACT

813-974-6827; Ariana.Rojas@epi.usf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): August 8, 2026
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Final datasets will be available at the NIDDK Central Repository 12 months from the last participant's follow-up visit
• Access Criteria: IPD can be requested through the NIDDK Central Repository once submitted.

Locations

US (1)